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Figure 1.
Trial Flow Diagram
Trial Flow Diagram

UMC indicates usual medical care.

Figure 2.
Adjusted Mean Low Back Pain (LBP) Intensity and Disability Over Time by Site
Adjusted Mean Low Back Pain (LBP) Intensity and Disability Over Time by Site

Estimated from mixed-effects models using all observed data, an unstructured covariance, and terms in the model for time (as a categorical variable), site, and site × group, time × group, and site × time × group interactions, adjusted for sex, age, pain duration, and worst pain during the past 24 hours. Low back pain intensity during the prior week was assessed by the Numerical Rating Scale (scores ranging from 0 [no LBP] to 10 [worst possible LBP]); LBP-related functional disability was assessed by the Roland Morris Disability Questionnaire (scores ranging from 0-24, with higher scores indicating greater disability). Walter Reed indicates Walter Reed National Military Medical Center, Bethesda, Maryland; Pensacola indicates Naval Hospital Pensacola, Pensacola, Florida; and San Diego indicates Naval Medical Center San Diego, San Diego, California.

Table 1.  
Baseline Characteristics of 750 Participants
Baseline Characteristics of 750 Participants
Table 2.  
Adjusted Within-Group Means and Between-Group Differences of Means in LBP and Disabilitya
Adjusted Within-Group Means and Between-Group Differences of Means in LBP and Disabilitya
Table 3.  
Within-Group Percentage of Responders and Between-Group RRs for Primary Outcomesa
Within-Group Percentage of Responders and Between-Group RRs for Primary Outcomesa
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    8 Comments for this article
    EXPAND ALL
    Integrated Care For Chronic Illness
    Frederick P. Rivara, MD, MPH | University of Washington, Seattle
    As a sufferer myself of chronic low back pain, I was very interested to see the results of this comparative effectiveness trial. To me, it points out the importance of integrated care for the treatment of chronic conditions. What are the likely barriers to implementing this in medical practices in general? Do we really need more research on the right treatments for low back pain?
    CONFLICT OF INTEREST: Editor in Chief, JAMA Network Open
    RE: Integrated Care For Chronic Illness
    Travis McKay, DC | Chiropractor, Clinical Director, Advanced Back & Neck Pain Center, Newark, DE
    Dr. Rivara, you are absolutely right about the importance of integrated care, especially with regards to mechanically based spine pain. As a chiropractor in private practice, what I see as the biggest barriers to making this happen are limitations in insurance coverage for patients seeking to utilize alternative pain management therapies, as well as a lack of available education for front line physicians i.e., PCPs, family physicians, internal medicine doctors, ED doctors, etc., about the benefits of a treatment such as chiropractic, especially when it's used in conjunction with medical care.

    I've seen numerous studies throughout
    the literature, in Spine, JMPT, Manual Therapy, etc., that highlight the benefits of chiropractic for mechanical spine pain, but unless an already busy physician is actively seeking it out, how are they ever going to come across it?

    CONFLICT OF INTEREST: None Reported
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    Questions on Usual Medical Care + Chiropractic Care vs. Usual Medical Care Alone
    Lynn Shaffer, PhD | Mount Carmel Health System
    There are a few points to consider in interpreting this article. First, the study participants' increased expectations of improvement w/ chiropractic care (score on a 10-point scale of 8.3/8.4 for chiropractic vs. 5.0/5.2 for usual medical care, Table 1) in this non-blinded trial probably account for the results which favored chiropractic plus usual medical care. This is reflected in the very strong odds ratios for global perceived improvement at 6 weeks (0.18) in favor of chiropractic compared to the marginal improvements seen in the primary outcomes of numeric pain rating scale and Roland-Morris Disability questionnaire. Patients who received assignment to their favored group perceived greater benefit based on their expectations rather than the chiropractic care.

    Second, protocol specific aim #1 is to: "assess the effectiveness of chiropractic manipulative therapy (CMT) for pain management and improved function in active duty service members with low back pain that do not require surgery," however, chiropractic care included other modalities beyond CMT which can be offered independently of a chiropractor. Since Table 2 of the supplementary online content shows that the vast majority of patients received at least one additional therapeutic intervention, the question arises as to whether it was these additional therapies that made a difference? This is an important question since, if it is the case, these therapies can be offered through usual medical care and avoid adding another layer of interventions to patient care.

    What happened with the Back Pain Functional Scale outcomes (listed in protocol)? I could not find this reported either in the main paper or in the supplemental material.
    CONFLICT OF INTEREST: None Reported
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    When is Alternative Medicine Justified?
    Gordon RUBENFELD, MD | University of Toronto
    I must confess an interest in chiropractic and many other alternative modalities since teaching courses to the passionate naturopathic students at Bastyr University in Seattle. Unfortunately, the vast majority of treatments we in traditional medicine would call alternative have not been subjected to nearly the rigorous evaluation in this paper. Due respect to anyone who would point out the same limitation for many treatments provided in my ICU.

    That said, and disclosing my own low Bayesian prior that external forces can fix a "subluxation" that may not exist or even account for low back pain, this is
    a nice pragmatic evaluation of an intervention.

    Critiques of the trial? Yes, of course. I would have liked to have seen a sham manipulation arm with massage or some other form of touching so we know the effect was from chiropractic and not just a non-specific response to the human interaction. I would like to see a more careful analysis of pain medication use (the only one I saw was in eTable 3 which showed no difference in prescriptions for spinal pain medications including new or changed ones).

    But, we have to acknowledge our failure in traditional medicine to address many of the debilitating maladies of everyday life including obesity, chronic pain, and fatigue. We need to have an open mind to rigorous research of alternative modalities that may offer safer and more effective options than NSAIDs, opioids, SSRIs, GABA analogs and needlessly expensive diagnostic workups.

    It would be great to hear from some primary care providers about how they will use this study? If you wanted to refer to a chiropractor would you even know how to find a good one?
    CONFLICT OF INTEREST: Associate Editor JAMA Network Open
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    A Flawed Premise
    Philip Timms, FRCPsych | South London & Maudsley NHS Foundation Trust
    Given the effort that has gone into this, a great pity. But, it seems to me that adding in almost any therapy that includes some sort of physical contact and, perhaps more importantly, therapist time with a patient, is likely to produce positive results.

    This study is certainly reassuring, as chiropractic interventions do not seem to have harmed participants. However, to persuade me that such chiropractic interventions are useful in themselves rather than via a placebo effect, I would like to see it compared with another "touch and time" intervention such as massage.
    CONFLICT OF INTEREST: None Reported
    RE: When is Alternative Medicine Justified?
    Benjamin Fonke, DC | Chiropractor, Private Practice in Cary NC
    Dr. Rubenfeld,

    I would like to offer an opinion as to how a primary care physician might go about finding a good chiropractor. I have been in private chiropractic practice for seven years and am a second-generation chiropractor. I believe that chiropractors and medical doctors have a lot to offer each other and our patients. There is a place for both treatments, especially when treating lower back pain (as this study highlights). My suggestion would be to reach out to colleagues who do a lot of work with lower back pain patients like Physiatrists,
    pain specialists, spine orthopedists, etc. See which chiropractors they have worked with and/or heard about. For example, I regularly co-manage patients with a local spine pain specialist (Physiatrist MD) and he has mentioned several of his patients that he has greater ease when injecting cortisone into the spine of my patients compared to others due to less inflammation and more spacing. He has referred many people to my office for treatment. Some MD's and DC's have no desire to work with each other due to philosophical differences (which is a shame), but this is not the case with all. If you find a good DC to co-manage patients with lower back pain, it will be good for all parties involved.

    With respect,

    Benjamin Fonke, DC
    CONFLICT OF INTEREST: None Reported
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    Integration and collaboration to reduce analgesic use
    Peter Emary, DC, MSc | PhD Student, Department of Health Research Methods, Evidence, and Impact, McMaster University
    We read with interest the clinical trial by Goertz et al.1 that was published in May 2018 in JAMA Network Open. Briefly, this study found that when added to usual medical care (UMC) chiropractic services resulted in statistically and clinically significant improvements in low back pain intensity, disability, and patient satisfaction at 6 weeks in active-duty military personnel. Overall, participants allocated to receive UMC with chiropractic care also reported significantly less analgesic use than those receiving UMC alone at 6- and 12-week follow-up (OR = 0.73; 95% CI, 0.54 to 0.97 and OR = 0.76; 95% CI, 0.58 to 1.00, respectively). In light of the current opioid crisis as well as recent evidence surrounding the prevention and treatment of low back pain, these findings warrant further discussion.

    Current clinical practice guidelines endorse the use of non-pharmacological treatment modalities such as education, manipulation, exercise, and reassurance as first-line interventions for the management of patients with low back pain. Guideline recommendations also include judicious use of diagnostic imaging, spinal injections, surgery, and opioids. In North America, the chiropractic profession has recently called on governments and other stakeholders to invest in further research regarding the opioid crisis and to create comprehensive approaches to managing patients with chronic non-cancer musculoskeletal pain.2 The clinical trial completed by Goertz et al.1 is in line with this call.

    From January 2014 to January 2016 we undertook a service evaluation of a new back pain service provided by chiropractors integrated into a primary care community health center setting in Ontario, Canada.3 Consistent with the findings by Goertz et al.,1 a majority of patients referred into the program reported clinically significant improvements in back pain intensity and functional disability at discharge. Additionally, more than three-quarters of patients did not visit any other health provider while under chiropractic care and almost all were satisfied with the service. Notably, a large majority of patients at follow-up also reported a significant reduction in the use of analgesics including opioids. A growing number of studies have similarly found decreases in analgesic usage when patients have been referred for chiropractic treatment.

    Owing to the positive treatment outcomes and reduced analgesic use with the addition of chiropractic care to UMC as reported by Goertz et al.1 and others, further research and integration of chiropractic services within multidisciplinary primary care, and other settings are warranted.

    Peter C. Emary, DC, MSc; Amy L. Brown, DC; and George A. Heckman, MD, MSc, FRCPC

    References
    1. Goertz CM, Long CR, Vining RD, Pohlman KA, Walter J, Coulter I. Effect of usual medical care plus chiropractic care vs usual medical care alone on pain and disability among US service members with low back pain: a comparative effectiveness clinical trial. JAMA Netw Open. 2018; 1(1):e180105.
    2. Canadian Chiropractic Association. A better approach to pain management: Responding to Canada’s opioid crisis; November 2016 [Available from: https://www.chiropractic.ca/wp-content/uploads/2016/11/A-Better-Approach-to-Pain-Management-in-Canada3-1.pdf (Accessed: 2 October 2017)].
    3. Emary PC, Brown AL, Cameron DF, Pessoa AF, Bolton JE. Management of back pain-related disorders in a community with limited access to health care services: a description of integration of chiropractors as service providers. J Manipulative Physiol Ther 2017; 40(9):635-642.
    CONFLICT OF INTEREST: None Reported
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    Author Clarifications
    Christine Goertz, DC, PhD | The Spine Institute for Quality
    My co-authors and I would like to express our appreciation to all who have provided commentary regarding our study “Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and Disability Among US Service Members With Low Back Pain: A Comparative Effectiveness Clinical Trial” and provide clarification regarding two key issues.

    First, there has been some confusion regarding whether or not study participants were allocated to treatment group through randomization. Several allocation methods are listed as acceptable in CONSORT 2010 guidelines, including design-adaptive minimization. (1) We chose this approach in allocating participants to
    treatment group rather than restricted or unrestricted randomization based on concerns regarding heterogeneity across treatment sites and the potential risks of imbalanced allocation within sites. This method was used successfully in our trial to balance known prognostic factors (sex, duration of low back pain, age and low back pain intensity) across treatment groups within sites.

    Second, some readers have questioned why we did not compare chiropractic care to a sham treatment and/or why we took a multi-modal approach to treatment. It is important to put this study in context of the existing literature. Dozens of explanatory randomized clinical trials have been published comparing chiropractic care and/or spinal manipulation to sham or other active treatments, the majority of which included spinal manipulation as an isolated treatment. (2,3) Thus, the current research focused on the practical value of adding a package of chiropractic care to medical care using pragmatic methods in order to answer a question of interest to the military: does the addition of chiropractic care improve patient outcomes. We believe such research is critical given the public health burden resulting from the combination of low back pain and the opioid crisis, which emphasizes the need to test non-pharmacological healthcare options for their safety and efficacy in real-world settings. As stated in the invited editorial by Dr. Dan Cherkin, (4) this trial represents an important contribution to the current state of knowledge regarding the addition of chiropractic care to improve low back pain care for military populations.

    1. Scott NW, McPherson GC, Ramsay CR, Campbell MK. The method of minimization to clinical trials. A review. Control Clin Trials 2002; 23:662-674.
    2. Chou R, Deyo R, Friedly J, Skelly A, Hashimoto R, Weimer M, et al. Nonpharmacologic Therapies for Low Back Pain: A Systematic Review for an American College of Physicians Clinical Practice Guideline. Ann Intern Med. 2017;166:493-505.
    3. Paige NM, Miake-Lye IM, Booth MS, Beroes JM, Mardian AS, Dougherty P, et al. Association of Spinal Manipulative Therapy With Clinical Benefit and Harm for Acute Low Back Pain: Systematic Review and Meta-analysis. JAMA. 2017;317:1451-1460.
    4. Cherkin DC. Innovating to Improve Care for Low Back Pain in the Military Chiropractic Care Passes Muster. JAMA Network Open. 2018;1(1):e180106. doi:10.1001/jamanetworkopen.2018.0106
    CONFLICT OF INTEREST: I am the primary author of this paper
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    Original Investigation
    Physical Medicine and Rehabilitation
    May 18, 2018

    Effect of Usual Medical Care Plus Chiropractic Care vs Usual Medical Care Alone on Pain and Disability Among US Service Members With Low Back Pain: A Comparative Effectiveness Clinical Trial

    Author Affiliations
    • 1Palmer College of Chiropractic, Palmer Center for Chiropractic Research, Davenport, Iowa
    • 2Parker University Research Institute, Dallas, Texas
    • 3Samueli Institute for Information Biology, Silver Spring, Maryland
    • 4RAND Corporation, Santa Monica, California
    JAMA Netw Open. 2018;1(1):e180105. doi:10.1001/jamanetworkopen.2018.0105
    Key Points

    Question  What is the effect of adding chiropractic care to usual medical care for patients with low back pain?

    Findings  In this comparative effectiveness clinical trial among active-duty US military personnel, patients who received usual medical care plus chiropractic care reported a statistically significant moderate improvement in low back pain intensity and disability at 6 weeks compared with those who received usual care alone.

    Meaning  This trial supports the inclusion of chiropractic care as a component of multidisciplinary health care for low back pain, as currently recommended in existing guidelines.

    Abstract

    Importance  It is critically important to evaluate the effect of nonpharmacological treatments on low back pain and associated disability.

    Objective  To determine whether the addition of chiropractic care to usual medical care results in better pain relief and pain-related function when compared with usual medical care alone.

    Design, Setting, and Participants  A 3-site pragmatic comparative effectiveness clinical trial using adaptive allocation was conducted from September 28, 2012, to February 13, 2016, at 2 large military medical centers in major metropolitan areas and 1 smaller hospital at a military training site. Eligible participants were active-duty US service members aged 18 to 50 years with low back pain from a musculoskeletal source.

    Interventions  The intervention period was 6 weeks. Usual medical care included self-care, medications, physical therapy, and pain clinic referral. Chiropractic care included spinal manipulative therapy in the low back and adjacent regions and additional therapeutic procedures such as rehabilitative exercise, cryotherapy, superficial heat, and other manual therapies.

    Main Outcomes and Measures  Coprimary outcomes were low back pain intensity (Numerical Rating Scale; scores ranging from 0 [no low back pain] to 10 [worst possible low back pain]) and disability (Roland Morris Disability Questionnaire; scores ranging from 0-24, with higher scores indicating greater disability) at 6 weeks. Secondary outcomes included perceived improvement, satisfaction (Numerical Rating Scale; scores ranging from 0 [not at all satisfied] to 10 [extremely satisfied]), and medication use. The coprimary outcomes were modeled with linear mixed-effects regression over baseline and weeks 2, 4, 6, and 12.

    Results  Of the 806 screened patients who were recruited through either clinician referrals or self-referrals, 750 were enrolled (250 at each site). The mean (SD) participant age was 30.9 (8.7) years, 175 participants (23.3%) were female, and 243 participants (32.4%) were nonwhite. Statistically significant site × time × group interactions were found in all models. Adjusted mean differences in scores at week 6 were statistically significant in favor of usual medical care plus chiropractic care compared with usual medical care alone overall for low back pain intensity (mean difference, −1.1; 95% CI, −1.4 to −0.7), disability (mean difference, −2.2; 95% CI, −3.1 to −1.2), and satisfaction (mean difference, 2.5; 95% CI, 2.1 to 2.8) as well as at each site. Adjusted odd ratios at week 6 were also statistically significant in favor of usual medical care plus chiropractic care overall for perceived improvement (odds ratio = 0.18; 95% CI, 0.13-0.25) and self-reported pain medication use (odds ratio = 0.73; 95% CI, 0.54-0.97). No serious related adverse events were reported.

    Conclusions and Relevance  Chiropractic care, when added to usual medical care, resulted in moderate short-term improvements in low back pain intensity and disability in active-duty military personnel. This trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for low back pain, as currently recommended in existing guidelines. However, study limitations illustrate that further research is needed to understand longer-term outcomes as well as how patient heterogeneity and intervention variations affect patient responses to chiropractic care.

    Trial Registration  ClinicalTrials.gov Identifier: NCT01692275

    Introduction

    Musculoskeletal disorders are the second leading cause of disability worldwide, led by low back pain (LBP), with an estimated LBP prevalence among US adults of 20%.1-3 The direct costs of back pain in the United States in 2010 were $34 billion,4 with additional indirect costs including lost workplace productivity estimated at $200 billion.5 In the US military, LBP is one of the most common reasons members seek medical care6 and one of the most likely conditions to interrupt combat duty.6,7 Common medical therapies for LBP, including nonsteroidal anti-inflammatory drugs, opioids, spinal fusions, and epidural steroid injections, demonstrate limited effectiveness8-10; furthermore, many of these treatments have unacceptably high risk profiles.8,11-14

    The US opioid crisis15,16 creates an urgent need to evaluate cost-effective and low-risk nonpharmacological treatments. One option is chiropractic care. Doctors of chiropractic provide conservative care focused on diagnosis, treatment, comanagement, or referral for musculoskeletal conditions, including LBP.17 The primary therapeutic procedure used by doctors of chiropractic is spinal manipulative therapy.18

    The use of chiropractic care is common, with annual rates among US adults estimated between 8% and 14%.19,20 Current guidelines recommend the use of spinal manipulative therapy and/or chiropractic care for LBP.21,22 Although a previous pilot study of chiropractic care for active-duty US military patients with acute LBP showed promise,23 and chiropractic care is available at 66 military health treatment facilities worldwide,24 significant gaps in knowledge remain in military populations. These populations tend to be younger and more diverse in terms of race and ethnicity than those included in previous trials on spinal manipulation.25 This multisite, pragmatic clinical trial begins to address these gaps by investigating whether adding chiropractic care to usual medical care (UMC) improves outcomes for patients with LBP at military treatment facilities.

    Methods
    Study Design, Setting, and Participants

    A detailed study protocol was previously published,26 and the trial protocol is available in Supplement 1. This pragmatic, prospective, multisite, parallel-group comparative effectiveness clinical trial with adaptive allocation was conducted at 2 large military medical centers in major metropolitan areas (Walter Reed National Military Medical Center [hereafter referred to as “Walter Reed”], Bethesda, Maryland; and Naval Medical Center San Diego [hereafter referred to as “San Diego”], San Diego, California) and at 1 smaller hospital at a military training site (Naval Hospital Pensacola [hereafter referred to as “Pensacola”], Pensacola, Florida). Active-duty US military participants aged 18 to 50 years reporting LBP were eligible. Low back pain of any duration from a nonmusculoskeletal source, the presence of a contraindication to spinal manipulative therapy, recent spinal fracture, recent spinal surgery, and a diagnosis of posttraumatic stress disorder were exclusionary. Participants with radiculopathy were eligible if a further diagnostic evaluation or surgical referral was not necessary. Participants either were referred to the study by physicians who diagnose or manage LBP or were self-referred through posted advertisements. Physicians or Independent Duty Corpsmen conducted a screening examination to assess eligibility. The trial was approved by each site and participating institution’s institutional review board and was overseen by an independent data and safety monitoring committee. All participants provided written informed consent and were not compensated for participation. The study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

    Allocation

    Participants were allocated in equal proportions to UMC with chiropractic care or to UMC alone for 6 weeks, stratified by site. The data coordinating center programmed an adaptive computer-generated minimization algorithm to balance group assignment on sex, age, LBP duration, and worst pain intensity in the past 24 hours at baseline. Study personnel accessed the web application to make group assignments, and future allocations were concealed.

    Study Interventions
    Usual Medical Care

    In this pragmatic trial, UMC in both groups included any care recommended or prescribed by nonchiropractic military clinicians to treat LBP. Options included self-management advice, pharmacologic pain management, physical therapy, or pain clinic referral. Participants allocated to UMC alone were asked to avoid receiving chiropractic care for the active care period unless directed by their clinician. In both groups, frequency of treatment visits and procedures were determined individually based on the participant’s diagnosis or condition, response to care, and scheduling availability.

    UMC With Chiropractic Care

    Participants allocated to UMC with chiropractic care had UMC in addition to as many as 12 chiropractic visits during the active care period. The primary chiropractic procedure was spinal manipulative therapy in the low back and adjacent regions.18 Treatment decisions regarding manipulation type, location, and direction were based on patient diagnoses. Other factors included patient preference, prior response to care, paraspinal muscle hypertonicity, spinal joint hypomobility, and imaging findings. Additional therapeutic procedures may have included rehabilitative exercise, interferential current therapy, ultrasound therapy, cryotherapy, superficial heat, and other manual therapies.

    Blinding

    It was not possible to blind treating clinicians or participants to treatment assignment. However, all key study personnel and data analysts were blinded.

    Outcomes

    Sociodemographic and clinical information was obtained at baseline. Participants were classified by race and ethnicity based on self-report. These data were collected to determine the generalizability of study findings, which is important for studies of chiropractic care as previous trials have included primarily white participants not of Latino descent. Usual medical care data on physical therapy or specialty referrals and prescription medications for spine-related pain as well as Current Procedural Terminology codes describing treatments delivered by the doctor of chiropractic were abstracted from the electronic health record.

    Primary outcomes (eTable 1 in Supplement 2) were measured at baseline and 2, 4, 6, and 12 weeks after baseline via online self-report questions through an electronic data capture system.26 Primary and secondary end points were at 6 and 12 weeks, respectively.

    Coprimary Outcomes

    Average LBP intensity during the prior week was assessed by the Numerical Rating Scale (NRS; scores ranging from 0 [no LBP] to 10 [worst possible LBP]).27-29 Functional disability related to LBP was assessed by the Roland Morris Disability Questionnaire (RMDQ; scores ranging from 0-24, with higher scores indicating greater disability).30 Primary analyses compared adjusted means between groups at the primary and secondary end points. A secondary responder analysis compared the percentage of patients with at least 30% improvement from baseline at each end point.

    Secondary Outcomes

    Worst LBP intensity during the past 24 hours was assessed using the NRS. Bothersomeness of LBP symptoms in the past week was measured on a scale of 1 (not at all bothersome) to 5 (extremely bothersome).31 Pain medication use was collected by asking participants how often they took pain-relieving medication (both prescription and over-the-counter) during the past week (0, 1-2, 3-4, 5-6, or 7 days). Global LBP improvement was assessed by asking participants to rate their perceived LBP improvement since baseline on a 7-point scale (0 indicated completely gone; 6, much worse).32,33 Satisfaction with care was assessed with an NRS, with scores ranging from 0 (not at all satisfied) to 10 (extremely satisfied).

    Adverse Events

    Adverse events were documented by participants via online self-report questions answered at 2, 4, and 6 weeks, and from project managers who directly queried participants.

    Sample Size

    We anticipated that outcomes might vary by site owing to differing patient populations. Therefore, we calculated a sample size of 106 patients per group per site to provide adequate power to detect clinically important between-group differences.34 A Bonferroni-adjusted significance level of α = .025 accounted for the coprimary outcome variables, with standard deviations estimated from our pilot study. This provided 92% power to detect a between-group difference of at least 1.2 points on the NRS and 80% power to detect a difference of at least 2.4 points on the RMDQ35 at each site. We increased the sample size to 125 patients per group at each site to account for an estimated loss to follow-up of 15% at the week 6 end point.

    Statistical Analysis

    The data analysis plan was prespecified and is shown in Supplement 1.26 Analyses followed an intention-to-treat approach in which all participants’ data were analyzed according to their original treatment allocation. We used SAS/STAT (release 9.4; SAS Institute Inc) for data analyses. All observed data were used in the analyses. Regression models included terms for time, site, group, and site × group, time × group, and site × time × group interactions, adjusted for sex, age, pain duration, and worst pain during the past 24 hours. For all analyses, if the site × time × group interaction was significant at the α = .05 level, results from the adjusted final models were reported overall and by site.

    The coprimary outcome variables were modeled with linear mixed-effects regression over baseline and weeks 2, 4, 6, and 12. Bonferroni-corrected P ≤ .025 was used to determine whether between-group differences were statistically significant at weeks 6 and 12. The responder analyses of the coprimary outcome variables were modeled with a modified Poisson regression fit through generalized estimating equations.

    Two approaches to sensitivity analyses were used to examine possible effects of missing data on results of coprimary outcome variables. The first assumed that data were missing at random and the second was a tipping-point approach that assumed data were missing not at random. Multiple imputation with the Markov chain Monte Carlo method was used for both methods to impute missing values for the coprimary outcome variables at weeks 2, 4, 6, and 12.

    Continuous secondary outcome variables were analyzed with the same linear mixed-effects regression models described earlier (except satisfaction, which was collected through week 6), but P ≤ .05 was used to determine whether between-group differences were significant. Pain medication use and perceived global improvement were analyzed over baseline and weeks 2, 4, and 6 with a proportional odds model for ordinal categorical data fit through generalized estimating equations.

    Results
    Participants and Treatment Visits

    A total of 806 patients were screened between September 28, 2012, and November 20, 2015, with 750 (250 at each of the 3 sites) allocated to receive UMC with chiropractic care (375 participants) or UMC alone (375 participants) (Figure 1). Data collection was completed on February 13, 2016, and data analysis was conducted from March 7, 2016, through April 30, 2016. Demographic characteristics, in particular age, race, and LBP chronicity, differed between sites (Table 1). Overall, the mean (SD) participant age was 30.9 (8.7) years, 175 participants (23.3%) were female, and 243 participants (32.4%) were nonwhite. Forty-three participants (5.7%) reported current use of narcotic analgesics and 398 (53.1%) took nonsteroidal anti-inflammatory drugs for back pain. Among all participants, 439 (58.5%) had never been treated with chiropractic care.

    There were 102 participants in the UMC group who did not visit a UMC clinician: 6 at Walter Reed, 2 at Pensacola, and 94 at San Diego. Of the 273 patients who had at least 1 visit to a UMC clinician, the mean (SD) number of visits was 2.6 (2.3) at Walter Reed, 2.3 (2.3) at Pensacola, and 2.7 (2.5) at San Diego. There were 109 participants in the group receiving UMC with chiropractic care who did not visit a UMC clinician: 11 at Walter Reed and 98 at San Diego. Of the 266 patients who had at least 1 visit to a UMC clinician, the mean (SD) number of visits was 2.6 (3.1) at Walter Reed, 1.6 (1.6) at Pensacola, and 3.5 (3.0) at San Diego. Of the 350 participants who had at least 1 chiropractic visit, the mean (SD) number of visits was 4.7 (2.5) at Walter Reed, 5.4 (2.6) at Pensacola, and 2.3 (1.4) at San Diego.

    Primary Outcomes

    We found significant site × time × group interactions in all models. Adjusted mean differences between groups overall were consistently in favor of UMC with chiropractic care compared with UMC alone for the coprimary outcome variables of LBP intensity (mean difference, −1.1; 95% CI, −1.4 to −0.7) and disability (mean difference, −2.2; 95% CI, −3.1 to −1.2) at week 6 (Table 2) as well as at all 3 sites (Figure 2). Findings at week 12 were similar, but with a slightly smaller magnitude of difference (Table 2). Results of the sensitivity analysis showed effects in the same direction with similar magnitudes and statistical significance under both missing-at-random and missing-not-at-random approaches for plausible shift parameters of the coprimary outcome variables at all sites. The possible exception to this was week 6 RMDQ scores at Pensacola, for which a tipping point of 2.33 (mean difference, −1.44; 95% CI, −2.91 to 0.03) was found; however, we considered this to be an unlikely mean difference between participants with and without missing data. Relative risks (RRs) in the responder analysis were statistically significantly in favor of greater benefit for the group receiving UMC with chiropractic care compared with the group receiving UMC alone overall at week 6 (LBP intensity: RR = 1.43; 95% CI, 1.23 to 1.68; disability: RR = 1.35; 95% CI, 1.16 to 1.56) and week 12 (LBP intensity: RR = 1.43; 95% CI, 1.23 to 1.68; disability: RR = 1.26; 95% CI, 1.11 to 1.43) and at San Diego at weeks 6 and 12 but not at Walter Reed at weeks 6 or 12 or at Pensacola at week 12 (Table 3).

    Secondary Outcomes

    Overall at weeks 6 and 12, participants receiving UMC with chiropractic care, compared with UMC alone, reported significantly lower mean worst LBP intensity within the past 24 hours (week 6: mean difference, −1.2; 95% CI, −1.6 to −0.8; week 12: mean difference, −1.1; 95% CI, −1.6 to −0.7) and symptom bothersomeness (week 6: mean difference, −0.4; 95% CI, −0.6 to −0.2; week 12: mean difference, −0.4; 95% CI, −0.6 to −0.2); the differences at each site also were statistically significant, with the exception of bothersomeness at Walter Reed (Table 2). Participants receiving UMC with chiropractic care had significantly better global perceived improvement at 6 weeks at all sites (overall: odds ratio [OR] = 0.18; 95% CI, 0.13 to 0.25; Walter Reed: OR = 0.26; 95% CI, 0.16 to 0.42; Pensacola: OR = 0.18; 95% CI, 0.10 to 0.33; San Diego: OR = 0.13; 95% CI, 0.08 to 0.21). Similarly, those receiving UMC with chiropractic care had significantly greater mean satisfaction with care at 6 weeks at all sites (overall: mean difference, 2.5; 95% CI, 2.1 to 2.8; Walter Reed: mean difference, 2.0; 95% CI, 1.4 to 2.6; Pensacola: mean difference, 2.3; 95% CI, 1.6 to 3.0; San Diego: mean difference, 3.1; 95% CI, 2.5 to 3.7). Overall, participants allocated to receive UMC with chiropractic care self-reported significantly less pain medication use than those receiving UMC alone at week 6 (OR = 0.73; 95% CI, 0.54 to 0.97) and week 12 (OR = 0.76; 95% CI, 0.58 to 1.00), but not at any of the individual sites.

    Additional Therapeutic Procedures and UMC

    Chiropractic care consisted of several therapeutic procedures in addition to spinal manipulation (eTable 2 in Supplement 2). Use of these therapies varied substantially by site. Participants at Walter Reed were most likely to receive multiple ancillary therapies across the range of options, while most in San Diego received therapeutic exercise for strength and flexibility. Usual medical care included physical therapy referrals and prescription medication, with less variation across sites than that for chiropractic care (eTable 3 in Supplement 2).

    Adverse Events

    Three unrelated serious adverse events were reported. There were 62 adverse effects reported throughout the 6-week active care phase: 38 at Walter Reed, 16 at Pensacola, and 8 at San Diego. Of the 19 adverse effects reported by participants receiving UMC alone, 3 were due to prescribed medications, 4 were related to epidural injections, and 12 consisted of muscle or joint stiffness attributed to physical therapy or self-care recommendations. Of the 43 adverse effects reported by participants receiving UMC with chiropractic care, 38 were described as muscle or joint stiffness attributed to chiropractic care (37 events) or physical therapy (1 event), 1 was reported as indistinct symptoms following an epidural injection, 3 were described as pain, tingling, or sensitivity in an extremity without reference to a specific treatment, and 1 was a lower-extremity burning sensation for 20 minutes following spinal manipulative therapy.

    Discussion

    The changes in patient-reported pain intensity and disability as well as satisfaction with care and low risk of harms favoring UMC with chiropractic care found in this pragmatic clinical trial are consistent with the existing literature on spinal manipulative therapy in both military23 and civilian20,36-38 populations. The magnitude of mean between-group differences for both pain (NRS) and disability (RMDQ) are consistent with a moderate magnitude of effect as classified by the American College of Physicians and American Pain Society guidelines.34,37

    This trial has several important strengths. The first is its pragmatic design. The advantages and disadvantages of a pragmatic clinical trial when evaluating complex treatment approaches have been well argued.39 These issues were considered by the study team prior to protocol development within the context that (1) placebo-controlled trials of spinal manipulation exist,40,41 (2) chiropractic care is already integrated into more than half of military treatment facilities across the United States,42,43 and (3) spinal manipulation or chiropractic care is recommended as a first line of treatment for pain management in military and civilian guidelines.21,22 Furthermore, a pragmatic approach provides the opportunity to better understand the effect of chiropractic care as it is currently integrated and delivered within military health care settings as part of a multidisciplinary approach.44 This is important given the lack of consensus regarding optimal treatment regimens for LBP in general as well as chiropractic care specifically.

    Second, most trials of chiropractic care for LBP have compared it with other monotherapies or usual care. This study focused on understanding the effect of adding chiropractic care to UMC vs UMC alone, which is consistent with how military health care is provided. Results from this pragmatic design can directly inform military health care practices and shed light on the potential effect of chiropractic care in other integrated health care delivery settings, such as patient-centered medical homes.

    Third, this trial included a more diverse sample in terms of race, ethnicity, and age than found in prior studies of either chiropractic or spinal manipulation.25

    Fourth, our sample of 750 participants is the largest trial, to our knowledge, evaluating UMC with chiropractic care vs UMC alone, allowing us to look both across and within 3 military treatment facilities using standardized outcome measures. By addressing several important limitations, such as small sample sizes, real-world applicability, and inconsistencies in outcome measures identified in previous systematic reviews,20,36 our findings further support existing guidelines that recommend nonpharmacological treatments as a first line of treatment for LBP.22,37 This is a critically important issue as the US health care delivery system struggles to adequately address the challenges of managing LBP and the opioid epidemic.15,16

    Limitations

    Although our study findings strengthen the scientific evidence for the use of chiropractic care in patients with LBP, study limitations leave a number of questions unanswered. Some are inherent to the nonspecific nature of LBP, the treatment approach used, and trial design. As is true with all studies of LBP of musculoskeletal origin, the specific diagnosis was difficult to determine or confirm, contributing toward patient heterogeneity that is not ideally characterized and is thus difficult to account for in the analysis. This problem was potentially exacerbated by the use of broad inclusion criteria, which are characteristic of pragmatic designs to increase the generalizability of study findings. However, it is difficult to specify the extent to which this heterogeneity contributed to patient outcomes within the context of this trial. Similarly, the use of hands-on, multimodal interventions commonly delivered by doctors of chiropractic makes it difficult to mask participants to treatment group or to control for the fact that those with chiropractic care received more time and attention from clinicians. Furthermore, cross-contamination of treatment approaches among and between clinicians makes it difficult to specifically identify which component(s) of both UMC and chiropractic interventions were associated with the beneficial effects found in this trial.

    Additional limitations specific to the ways in which this particular trial was designed also exist. Participant visit numbers varied across sites for both UMC and chiropractic care. Although those enrolled across all 3 sites were encouraged in a similar manner to seek care based on their treatment group allocation, a larger number of participants in San Diego chose not to access UMC, a discrepancy that may explain why fewer participants at San Diego who received UMC alone were classified as respondents at 6 weeks. We attribute these differences in adherence to variations in trial recruitment strategies. At Walter Reed and Pensacola, most participants were recruited from primary care clinics by physicians, so they had already chosen to seek medical care for their LBP. The majority of participants at San Diego were recruited using flyers and screened for eligibility by Independent Duty Corpsmen. We do not know whether these participants chose not to access UMC (1) for logistical reasons, (2) because UMC had not been beneficial when used previously, or (3) for some other reason that may have affected their LBP outcomes. These are important considerations for future research.

    Differences in participant characteristics, treatments received, and outcomes across sites are also limitations. The use of standardized outcome measures and inclusion of 250 participants at each site addressed anticipated differences in patient and practice characteristics. However, this strategy was only partially successful. It is not surprising that Pensacola had the highest proportion of responders at 6 and 12 weeks for both primary outcomes, as participants here were younger and more likely to report acute LBP (<1 month). It is less clear why participants at San Diego, most likely to report chronic LBP (>3 months: >75%) and less likely to seek UMC, showed larger between-group differences in LBP disability at both end points even though they had approximately half the chiropractic visits found at the other 2 sites. Further work is needed to determine the effect of chiropractic visit numbers on outcomes.

    Another challenge, unique to conducting research in the military, was following patients who are highly transient, especially in times of war. When this study was designed, the active-duty population of interest was likely to be deployed. Consequently, we chose to follow participants for 12 weeks and excluded those who were scheduled to leave the country within that period. As a result, an additional limitation of this study is the relatively short follow-up.

    Conclusions

    Chiropractic care, when added to UMC, resulted in moderate short-term treatment benefits in both LBP intensity and disability, demonstrated a low risk of harms, and led to high patient satisfaction and perceived improvement in active-duty military personnel. This trial provides additional support for the inclusion of chiropractic care as a component of multidisciplinary health care for LBP, as currently recommended in existing guidelines.21,22,37 However, study limitations illustrate that further research is needed to understand longer-term outcomes as well as how patient heterogeneity and intervention variations affect patient responses.

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    Article Information

    Accepted for Publication: February 4, 2018.

    Open Access: This is an open access article distributed under the terms of the CC-BY License. © 2018 Goertz CM et al. JAMA Network Open.

    Corresponding Author: Christine M. Goertz, DC, PhD, Palmer College of Chiropractic, Palmer Center for Chiropractic Research, 741 Brady St, Davenport, IA 52803 (christine.goertz@palmer.edu).

    Author Contributions: Dr Long had full access to all of the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.

    Concept and design: Goertz, Long, Pohlman, Walter, Coulter.

    Acquisition, analysis, or interpretation of data: Goertz, Long, Vining, Pohlman, Walter.

    Drafting of the manuscript: Goertz, Long, Vining, Pohlman.

    Critical revision of the manuscript for important intellectual content: Long, Vining, Pohlman, Walter, Coulter.

    Statistical analysis: Long.

    Obtained funding: Goertz, Long, Walter, Coulter.

    Administrative, technical, or material support: Goertz, Vining, Pohlman, Walter.

    Supervision: Goertz, Long, Vining, Pohlman.

    Conflict of Interest Disclosures: Dr Goertz reported receiving personal fees from Spine IQ as chief executive officer and from the American Chiropractic Association as a consultant outside the submitted work; and owning stock in Prezacor, Inc. Dr Pohlman reported receiving an educational fellowship from NCMIC Foundation outside the submitted work. Ms Walter reported receiving grants from RAND Corporation during the conduct of the study; and receiving grants from the US Army Medical Research Acquisition Agency, Samueli Institute, and RAND Corporation outside the submitted work. Dr Coulter reported receiving grants from RAND Corporation during the conduct of the study. No other disclosures were reported.

    Funding/Support: This study was based on work supported by grant W81XWH-11-2-0107 to the RAND Corporation from the Chiropractic Research Program of the Congressionally Directed Medical Research Programs, US Army, US Department of Defense.

    Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

    Disclaimer: The views expressed are those of the authors and may not reflect the official policy or position of the US Department of the Army, US Department of Defense, or US government.

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